Work

Favorable outcomes of restrictive treatment indications in chronic lymphocytic leukemia: a retrospective analysis of Brazilian Registry of CLL

Year: 2025

Type: article

Abstract: Background The Brazilian Group of CLL (BGCLL) has proposed a more restrictive approach for treatment initiation compared to the International Workshop on Chronic Lymphocytic Leukemia (IWCLL) guidelines. Here, we report on the safety and efficacy of this strategy. Methods We performed a retrospective analysis of patients with CLL registered in the Brazilian CLL Registry between January 2009 and July 2023 who met the minimum data availability criteria for analysis. The BGCLL criteria employ stricter thresholds for cytopenias, defining them as hemoglobin levels below 9.5 g/dL or platelet counts below 50,000/mm 3 , as opposed to the IWCLL criteria of below 10 g/dL and below 100,000/mm 3 , respectively. Furthermore, the BGCLL criteria do not consider progressive lymphocytosis or disease-related symptoms to be criteria for treatment initiation when cytopenias or symptomatic masses are absent. Survival outcomes were estimated using the Kaplan–Meier method and compared with log-rank tests. Cox proportional hazards models were used for multivariable analysis, with results expressed as hazard ratios and 95% confidence intervals. A P-value <0.05 was considered statistically significant. Findings A total of 2511 patients were enrolled from 41 centers. Of these, 1404 patients (56%) met the IWCLL criteria for treatment initiation (liberal criteria), whereas only 788 patients (31%) met the BGCLL criteria (restrictive criteria). Patients with liberal criteria had a better overall survival than those with restrictive criteria (85% vs. 68%, respectively), suggesting that restrictive criteria were more predictive of prognosis than liberal criteria. In addition, patients treated for cytopenias had significantly worse overall survival (69%) compared to those treated for any other indication (97%, P < 0.0001). Patients with disease-related symptoms, progressive lymphocytosis, and extranodal involvement as isolated indications for treatment had similar overall survival to those with no indication for treatment. Interpretation Our results demonstrate that a more restrictive approach to treatment initiation in CLL, as proposed by the BGCLL, better identifies patients with higher disease burden and poorer outcomes, while sparing others unnecessary therapy. Funding Brazilian Registry of CLL–Brazilian Association of Hematology and Hemotherapy (ABHH)/Coordenação de Aperfeiçoamento de Pessoal de Nível Superior (CAPES).

Source: The Lancet Regional Health - Americas

DOI: 10.1016/j.lana.2025.101234